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NCT Number: NCT04969770

Evaluation of Biomechanical Modifications of the Neuromuscular Spine Fixed by Bipolar Construct

Neuromuscular scoliosis are caused by a disorder of the brain, spinal cord or muscular system and often progressive at early age. Conservative treatment is not sufficient to maintain trunk and pelvic balance, and surgical treatment is frequently required. Early definitive spine fusion has the disadvantage of cessation of trunk growth with concomitant effects on lung development. Growth preserving spine surgeries are increasingly used but with high complication rates.

The orthopaedic team at Necker Hospital Enfants maladies, Paris, France has developed an innovative fusionless surgery based on a bipolar spine construct, performed by a minimally invasive approach. The first 100 patients operated on with this technique had an average follow-up of 6.5 years. No arthrodesis, initially planned in adolescence, was necessary thanks to the stability of the correction of the deformities even after skeletal maturation.

The main objective of the study was to analyze the progressive spinal stiffening, using muscle and disc elastography, in neuromuscular patients instrumented with this bipolar construct.

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Key information

Conditions

Neuromuscular Scoliosis

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

Neuromuscular scoliosis is related to muscle tone abnormalities with a prognosis worsen by damage to the axial and respiratory muscles.

The classic treatment for these scoliosis consists of conservative treatment (physiotherapy, bracing), followed by arthrodesis in adolescence. Arthrodesis consists of a global posterior spinal fusion, with a high risk of septic and hemorrhagic complications.

In cases of early and rapidly progressive deformities, fusionless techniques allow the preservation of growth while waiting for arthrodesis. However, these techniques have a high rate of complications, particularly of mechanical and infectious origin, which led the orthopedic team at Necker Hospital, Paris, France to develop an innovative technique. This technique is based on bipolar construct, performed by a minimally invasive approach. The first 100 patients operated on have an average follow-up of 6.5 years. No arthrodesis, initially planned in adolescence for these patients, was necessary, thanks to the stability of the correction even after skeletal maturation.

The main objective of the study was to analyze the progressive spinal stiffening, using muscle and disc elastography, in neuromuscular patients instrumented with this bipolar construct.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Minor patients between 10 and <18 years old, presenting a neuromuscular pathology, with progressive scoliosis, to undergo for their clinical care a fusionless surgery based on a bipolar spine construct, performed by a minimally invasive approach
  • Minor patients between 10 and <18 years old, presenting a neuromuscular pathology such as encephalopathy / infantile spinal amyotrophy / myopathy, without progressive scoliosis
  • Minor patients between 10 and <18 years old, healthy controls, followed in orthopedics for a pathology other than neuromuscular or spinal deformity
  • Written informed consent

Exclusion criteria

  • No social insurance
  • Severe mental retardation or severe dystonia making data acquisition impossible or requiring sedation
  • Patients with gastrostomy or tracheostomy

Treatment and study plan

Ultrasound elastography (USE)

Other

Visualization of the vertebral disc and the para-vertebral muscles.

Intra and inter observer reproducibility analysis carried out for each of the measurements made, by two operators.

Patients with instrumented neuromuscular scoliosis: 5 elastographies : preoperatively, then during the usual follow-up consultations with the surgeon every 6 months for 2 years.

Patients with neuromuscular pathologies without instrumented scoliosis: 4 elastographies during the usual follow-up consultations with the surgeon every 6 months for 2 years.

Healthy control patients without neuromuscular pathology or scoliosis :

1 elastography during an usual consultation.

Primary outcomes

  1. Discal stiffness

    Time frame: 2 years

    Ultrasound elastography (USE) Measurements performed in the transverse plane of L3-L4 intervertebral disc. A rectangular strip is selected and a series of 3 clips of 10 seconds (i.e., 30 images) is recorded. The average of these measurements is reported.

  2. Paravertebral muscular stiffness

    Time frame: 2 years

    Ultrasound elastography (USE) Measurement performed in the longitudinal plane, in the axis of muscular fibers and in the middle of multifidus muscle.

    A rectangular strip is selected and a series of 3 clips of 10 seconds (i.e. 30 images) is recorded. The average of these measurements is reported in rest and passive stretching position, on the right side and on the left side.

Secondary outcomes

  1. Parameters influencing the progressive stiffening of the spine

    Time frame: 2 years

    Research and description of clinical parameters influencing the progressive stiffening of the spine, e.g. , age, etiology, spinal deformity and correction, BMI

  2. Biomechanical characteristics of the construct

    Time frame: 2 years

    Influence of spinal stiffness on biomechanical characteristics of the construct : distance between the rods and the spine, causing an osteo-inductive process

  3. Occurrence of rod fracture

    Time frame: 2 years

    Occurrence or not of a rod fracture on X-rays

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Contribution of Muscle and Disc Elastography in the Evaluation of Biomechanical Modifications of the Neuromuscular Spine Fixed by Bipolar Construct

Acronym: ELASTO

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2021
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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